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Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B

Primary Purpose

Chronic Hepatitis B

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
TDF
Peg-IFN
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Chronic Hepatitis B, Hep B, Non cirrhotic, Tenofovir disoproxil fumarate (TDF), Peginterferon α-2a (Peg-IFN)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults (age 18-75) with chronic HBV (positive for serum hepatitis B surface antigen (HBsAg) or HBV DNA for at least 6 months) prior to baseline
  • Anti-HBV treatment-naive adults; adults who have taken oral anti-HBV nucleoside therapy with the last dose ≥ 24 weeks prior to screening are also eligible.
  • Positive or negative for hepatitis B e antigen (HBeAg)
  • HBV DNA ≥ 20,000 IU/ml (HBeAg-positive participants) and ≥ 2,000 IU/ml (HBeAg-negative participants)
  • Alanine aminotransferase (ALT) > 54 U/L and ≤ 400 U/L for men and > 36 U/L and ≤ 300 U/L for women
  • Creatinine clearance ≥ 70 mL/min
  • Negative serum pregnancy test for females of childbearing potential
  • Sexually active females of childbearing potential must agree to use a protocol-recommended method of contraception throughout the study and for 30 days following the last dose of study medication
  • Lactating females must agree to discontinue nursing before initiation of study investigational medicinal product

Exclusion Criteria:

  • Known bridging fibrosis or cirrhosis and/or decompensated liver disease
  • Evidence of hepatocellular carcinoma
  • Significant kidney, heart, lung, neurological, autoimmune disease, or bone disease (eg, osteomalacia,chronic osteomyelitis, osteogenesis imperfecta, osteochondrosis, multiple bone fractures)
  • Absolute neutrophil count < 1,500/mm^3, platelet < 100,000/mm^3, hemoglobin < 10 g/dL (female) or < 11 g/dL (male)
  • History of severe depression or severe psychiatric disease
  • Thyroid dysfunction
  • Coinfection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV)
  • Pregnant

Sites / Locations

  • Asian Pacific Liver Center
  • Stanford University Medical Center
  • Research and Education Inc
  • San Jose Gastroenterology
  • Avail Clinical Research, LLC
  • Centre for Advanced Gastroenterology
  • University of Miami / Jackson Memorial Medical Center
  • University of Chicago
  • LSU Gastroenterology/Center for Digestive Diseases
  • Tulane University Hospital and Clinic
  • Digestive Disease Associates
  • Tufts Medical Center
  • Henry Ford Hospital
  • ID Care, Inc.
  • Medical Procare, PLLC
  • North Shore University Hospital
  • Beth Israel Medical Center
  • New York Univ. Medical Center
  • Weill Cornell Medical College of Cornell University
  • Private Practice
  • Advanced Liver Therapies at St. Luke's Episcopal Hospital
  • Kelsey Research Foundation
  • Liver Associates of Texas,
  • University of Utah
  • Liver Institute of Virginia, Bon Secours Health System
  • McGuire Research Institute
  • Royal Prince Alfred Hospital
  • Concord Repatriation General Hospital
  • Saint George's Hospital
  • Liverpool Hospital,Gastroenterology Department
  • Westmead Hospital
  • Royal Brisbane & Women's Hospital
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Flinders Medical Center
  • Monash Medical Centre
  • Saint Vincents Hospital
  • Western Hospital
  • Austin Health
  • Alfred Hospital
  • Box Hill Hospital
  • Royal Melbourne Hospital
  • Fremantle Hospital
  • Sir Charles Gairdner Hospital
  • Royal Perth Hospital
  • Heritage Med Research Clinic, Univ of Calgary
  • University of Alberta, Zeidler Ledcore Centre
  • Gastrointestional Research Institute
  • Gordon & Leslie Diamond Health Care Centre
  • Liver and Intestinal Research Centre
  • The Ottawa Hospital,Division of Infectious Diseases
  • Toronto General Hospital
  • Toronto Liver Centre
  • Hôpital Beaujon, Service Hepatologie- Centre Pierre Abrami
  • Hôpital de la Croix Rousse
  • Hopital Tenon
  • Centre Hospitalier Universitaire de Rennes
  • Hopital Charles Nicolle
  • Centre Hospitalier Regional et Universitaire de Strasbourg, Hopital Civil
  • Centre Hospitalier Universitaire Purpan
  • Hopital Paul Brousse
  • Johannes Gutenberg-Universitat Mainz,
  • Charite Berlin
  • Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie,
  • Johann-Wolfgang-Goethe Universitat,
  • Asklepios Westklinikum
  • Medizinische Hochschule Hannover,Hastroenterologie und Hepatologie
  • Universitatsklinik Koln
  • Universitatsklinikum Leipzig
  • Ippokratio Hospital Salonica
  • Ippokratio Hospital Athens
  • General University Hospital of Patras
  • Hippokration General Hospital of Thessaloniki
  • Queen Mary Hospital
  • Princess Margaret Hospital
  • Prince of Wales Hospital
  • Alice Ho Miu Ling Nethersole Hospital
  • Global Hospital, Lakdi Ka Pul
  • Institute of digestive and liver disease, Dispur Hospital Ganeshguri
  • Vedanta Institute of Medical Sciences
  • Liver Clinic
  • Manipal Hospitals
  • Department of Hepatology, Institute of Liver Diseases, HPB Surgery and Transplant, Global Hospital
  • Seth GS Medical College and KEM Hospital, Acharya Donde Marg,Parel
  • Midas Institute of Gastroenterology
  • Dharamasi Hospital,Chandni Chowk, South Shivajinagar,
  • All India Institute of Medical Sciences, Ansari Nagar
  • VGM Hospital
  • Institute of Post Graduate Medical Education And Research
  • Institute of Liver and Biliary Sciences
  • Azienda Ospedaliero-Universitaria di Cagliari
  • Fondazione IRCCS Ca Granda - Ospedale Maggiore Policlinico
  • Ospedale San Raffaele
  • Seconda Universita degli Studi di Napoli
  • Azienda Ospedaliera di Parma,Department of Infectious Diseases and hepatology
  • Fondazione PTV - Policlinico Tor Vergata
  • Policlinico Umberto I
  • University of Milan,Azienda Ospedaliera San Giovanni, Battista di Torino,Dipartimento di Gastroenterologia
  • SoonChunHyang University Hospital Cheonan
  • Yonsei Unversity Wonju College of Medicine Wonju Christian Hospital
  • Korea University Ansan Hospital
  • Bucheon St. Mary's Hospital
  • Korea University Guro Hospital
  • CHA Bundang Medical Center, CHA University
  • Pusan National University Hospital
  • Kyungpook National University Hospital
  • Pusan National University Yangsan Hospital
  • Inje University Busan Paik Hospital
  • Inje University Ilsan Paik Hospital
  • Digestive Disease Cntr, Konkuk Univ Hosp
  • Asan Medical Center
  • Gangnam Severance Hospital
  • Konkuk University Medical Center
  • Samsung Medical Center
  • Seoul National University Hospital
  • Seoul Saint Mary's Hospital
  • Academisch Medisch Centrum
  • Vrije Universiteit Medisch Centrum
  • Erasmus Medisch Centrum
  • Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi
  • Samodzielny Publiczny Szpital Kliniczny 1,Klinika Chorób Zakaznych,ulica Staszica 16
  • Szpital Specjalistyczny w Chorzowie
  • Wojewodzki Szpital Specjalistyczny Kazimierza Dluskeigo w Bialymstoku
  • Wojewódzki Szpital Obserwacyjno Zakazny im. Tadeusza Browicza
  • Szpital Uniwersytecki w Krakowie
  • Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi
  • SP ZOZ Wojewodzki Szpital Zakazny
  • Hospital de Egas Moniz
  • Hospital de Santa Maria
  • Centro Hospitalar do Porto
  • Hospital São João
  • Neomed Research
  • Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
  • Institutul National de Boli Infectioase Prof.Dr. Matei Bals
  • Spitalul Clinic de Boli Infectioase si Tropicale "Dr. Victor Babes"
  • Spitalul Clinic Colentina
  • Spitalul Clinic Judetean de Urgenta Sibiu
  • Cabinet Particular Policlinic Algomed SRL-Gastroenterologie
  • Changi General Hospital
  • National University Hospital Singapore
  • Singapore General Hospital
  • Tan Tock Seng Hospital
  • Hospital General Universitari Vall d' Hebron
  • Hospital Carlos III
  • Hospital Universitario de La Princesa
  • Hospital Virgen de la Victoria
  • Hospital Universitario Virgen del Rocio
  • Hospital Meixoeiro
  • Far-Eastern Memorial Hosp
  • Chang Gung Medical Foundation.LinKou Branch
  • Changhua Christain Hospital
  • Chiayi Christian Hosp
  • Buddhist Tzu Chi General Hospital
  • Chang Gung Memorial Hospital
  • Kaohsiung Medical University Hospital
  • Chang Gung Medical Foundation-Keelung
  • China Medical University Hospital
  • Chung Shan Medical University Hospital
  • Taichung Veterans Genl Hosp
  • National Cheng Kung University Hospital
  • Cathay General Hospital
  • National Taiwan University Hospital
  • Ankara Üniversitesi Tip Fakültesi
  • Hacettepe Üniversitesi Tip Fakültesi
  • Gaziantep Üniversitesi Tip Fakültesi, Sahinbey Arastirma ve Uygulama Hastanesi
  • Istanbul Universitesi Istanbul Tip Fakultesi
  • Mersin Üniversitesi Tip Fakültesi, Saglik Arastirma ve Uygulama Hastanesi
  • The Queen Elizabeth Hospital
  • Royal Free Hospital
  • Barts and The London NHS Trust
  • King's College Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

TDF+Peg-IFN 48 Weeks

TDF 48 Weeks + Peg-IFN 16 Weeks

TDF 120 Weeks

Peg-IFN 48 Weeks

Arm Description

TDF plus Peg-IFN for 48 weeks

TDF plus Peg-IFN for 16 weeks, followed by TDF alone for an additional 32 weeks

TDF monotherapy for 120 weeks

Peg-IFN monotherapy for 48 weeks

Outcomes

Primary Outcome Measures

Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis.

Secondary Outcome Measures

Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With TDF (48 Weeks) Plus Peg-IFN (16 Weeks) Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis.
Percentage of Participants With HBsAg Loss at Weeks 96 and 120
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 96 comprised study Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised study Week 114 through Week 126, so results up to Week 126 are included in this analysis.
Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120
HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis. The analysis visit window for Week 96 comprised Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised Week 114 through Week 120.
Percentage of Participants With HBeAg Loss and Seroconversion at Week 72
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit. For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 72, and in the "Retreated" column for participants who did enter the retreatment phase by Week 72.
Percentage of Participants With HBeAg Loss and Seroconversion at Week 96
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit. For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 96, and in the "Retreated" column for participants who did enter the retreatment phase by Week 96.
Percentage of Participants With HBeAg Loss and Seroconversion at Week 120
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit. For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 120, and in the "Retreated" column for participants who did enter the retreatment phase by Week 120.
Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 72, and in the "Retreated" column for participants who did enter the retreatment phase by Week 72.
Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 96, and in the "Retreated" column for participants who did enter the retreatment phase by Week 96.
Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 120, and in the "Retreated" column for participants who did enter the retreatment phase by Week 120.
Percentage of Participants With Normal ALT at Week 72
Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT). For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 72, and in the "Retreated" column for participants who did enter the retreatment phase by Week 72.
Percentage of Participants With Normal ALT at Week 96
Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT). For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 96, and in the "Retreated" column for participants who did enter the retreatment phase by Week 96.
Percentage of Participants With Normal ALT at Week 120
Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT). For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 120, and in the "Retreated" column for participants who did enter the retreatment phase by Week 120.
Percentage of Participants Who Required Retreatment
Participants in the TDF 120 week group were not eligible to enter the retreatment phase and are not presented.

Full Information

First Posted
January 13, 2011
Last Updated
July 15, 2016
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01277601
Brief Title
Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B
Official Title
A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination With Peginterferon α-2a (Pegasys®) Versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the efficacy of tenofovir disoproxil fumarate (TDF) plus peginterferon α-2a (Peg-IFN) combination therapy for 48 weeks versus standard of care TDF monotherapy or Peg-IFN monotherapy for 48 weeks in non-cirrhotic adults with chronic hepatitis B virus (HBV) as determined by loss of hepatitis B surface antigen (HBsAg). The study will consist of 2 phases for participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups. Following an initial 48 weeks of treatment, participants in these groups will be monitored for 24 weeks for signs of worsening HBV, and those meeting TDF retreatment and flare management criteria will be eligible to receive TDF monotherapy during a retreatment phase, up to Week 120.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
Chronic Hepatitis B, Hep B, Non cirrhotic, Tenofovir disoproxil fumarate (TDF), Peginterferon α-2a (Peg-IFN)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
751 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TDF+Peg-IFN 48 Weeks
Arm Type
Experimental
Arm Description
TDF plus Peg-IFN for 48 weeks
Arm Title
TDF 48 Weeks + Peg-IFN 16 Weeks
Arm Type
Experimental
Arm Description
TDF plus Peg-IFN for 16 weeks, followed by TDF alone for an additional 32 weeks
Arm Title
TDF 120 Weeks
Arm Type
Active Comparator
Arm Description
TDF monotherapy for 120 weeks
Arm Title
Peg-IFN 48 Weeks
Arm Type
Active Comparator
Arm Description
Peg-IFN monotherapy for 48 weeks
Intervention Type
Drug
Intervention Name(s)
TDF
Other Intervention Name(s)
Viread®
Intervention Description
TDF 300 mg tablets administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Peg-IFN
Other Intervention Name(s)
Pegasys®
Intervention Description
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Primary Outcome Measure Information:
Title
Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone
Description
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis.
Time Frame
Baseline; Week 72
Secondary Outcome Measure Information:
Title
Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With TDF (48 Weeks) Plus Peg-IFN (16 Weeks) Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone
Description
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis.
Time Frame
Baseline; Week 72
Title
Percentage of Participants With HBsAg Loss at Weeks 96 and 120
Description
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 96 comprised study Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised study Week 114 through Week 126, so results up to Week 126 are included in this analysis.
Time Frame
Baseline; Weeks 96 and 120
Title
Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120
Description
HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis. The analysis visit window for Week 96 comprised Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised Week 114 through Week 120.
Time Frame
Baseline; Weeks 72, 96, and 120
Title
Percentage of Participants With HBeAg Loss and Seroconversion at Week 72
Description
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit. For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 72, and in the "Retreated" column for participants who did enter the retreatment phase by Week 72.
Time Frame
Baseline; Week 72
Title
Percentage of Participants With HBeAg Loss and Seroconversion at Week 96
Description
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit. For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 96, and in the "Retreated" column for participants who did enter the retreatment phase by Week 96.
Time Frame
Baseline; Week 96
Title
Percentage of Participants With HBeAg Loss and Seroconversion at Week 120
Description
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit. For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 120, and in the "Retreated" column for participants who did enter the retreatment phase by Week 120.
Time Frame
Baseline; Week 120
Title
Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72
Description
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 72, and in the "Retreated" column for participants who did enter the retreatment phase by Week 72.
Time Frame
Week 72
Title
Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96
Description
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 96, and in the "Retreated" column for participants who did enter the retreatment phase by Week 96.
Time Frame
Week 96
Title
Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120
Description
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 120, and in the "Retreated" column for participants who did enter the retreatment phase by Week 120.
Time Frame
Week 120
Title
Percentage of Participants With Normal ALT at Week 72
Description
Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT). For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 72, and in the "Retreated" column for participants who did enter the retreatment phase by Week 72.
Time Frame
Week 72
Title
Percentage of Participants With Normal ALT at Week 96
Description
Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT). For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 96, and in the "Retreated" column for participants who did enter the retreatment phase by Week 96.
Time Frame
Week 96
Title
Percentage of Participants With Normal ALT at Week 120
Description
Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT). For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 120, and in the "Retreated" column for participants who did enter the retreatment phase by Week 120.
Time Frame
Week 120
Title
Percentage of Participants Who Required Retreatment
Description
Participants in the TDF 120 week group were not eligible to enter the retreatment phase and are not presented.
Time Frame
Up to 120 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults (age 18-75) with chronic HBV (positive for serum hepatitis B surface antigen (HBsAg) or HBV DNA for at least 6 months) prior to baseline Anti-HBV treatment-naive adults; adults who have taken oral anti-HBV nucleoside therapy with the last dose ≥ 24 weeks prior to screening are also eligible. Positive or negative for hepatitis B e antigen (HBeAg) HBV DNA ≥ 20,000 IU/ml (HBeAg-positive participants) and ≥ 2,000 IU/ml (HBeAg-negative participants) Alanine aminotransferase (ALT) > 54 U/L and ≤ 400 U/L for men and > 36 U/L and ≤ 300 U/L for women Creatinine clearance ≥ 70 mL/min Negative serum pregnancy test for females of childbearing potential Sexually active females of childbearing potential must agree to use a protocol-recommended method of contraception throughout the study and for 30 days following the last dose of study medication Lactating females must agree to discontinue nursing before initiation of study investigational medicinal product Exclusion Criteria: Known bridging fibrosis or cirrhosis and/or decompensated liver disease Evidence of hepatocellular carcinoma Significant kidney, heart, lung, neurological, autoimmune disease, or bone disease (eg, osteomalacia,chronic osteomyelitis, osteogenesis imperfecta, osteochondrosis, multiple bone fractures) Absolute neutrophil count < 1,500/mm^3, platelet < 100,000/mm^3, hemoglobin < 10 g/dL (female) or < 11 g/dL (male) History of severe depression or severe psychiatric disease Thyroid dysfunction Coinfection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV) Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Belinda Jump
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Asian Pacific Liver Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
Country
United States
Facility Name
Research and Education Inc
City
San Diego
State/Province
California
Country
United States
Facility Name
San Jose Gastroenterology
City
San Jose
State/Province
California
Country
United States
Facility Name
Avail Clinical Research, LLC
City
Deland
State/Province
Florida
Country
United States
Facility Name
Centre for Advanced Gastroenterology
City
Maitland
State/Province
Florida
Country
United States
Facility Name
University of Miami / Jackson Memorial Medical Center
City
Miami
State/Province
Florida
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
LSU Gastroenterology/Center for Digestive Diseases
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Tulane University Hospital and Clinic
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Digestive Disease Associates
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
ID Care, Inc.
City
Hillsborough
State/Province
New Jersey
Country
United States
Facility Name
Medical Procare, PLLC
City
Flushing
State/Province
New York
Country
United States
Facility Name
North Shore University Hospital
City
Great Neck
State/Province
New York
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
New York Univ. Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
Weill Cornell Medical College of Cornell University
City
New York
State/Province
New York
Country
United States
Facility Name
Private Practice
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Advanced Liver Therapies at St. Luke's Episcopal Hospital
City
Houston
State/Province
Texas
Country
United States
Facility Name
Kelsey Research Foundation
City
Houston
State/Province
Texas
Country
United States
Facility Name
Liver Associates of Texas,
City
Houston
State/Province
Texas
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Liver Institute of Virginia, Bon Secours Health System
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
McGuire Research Institute
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
Country
Australia
Facility Name
Saint George's Hospital
City
Kogarah
State/Province
New South Wales
Country
Australia
Facility Name
Liverpool Hospital,Gastroenterology Department
City
Liverpool
State/Province
New South Wales
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
Royal Brisbane & Women's Hospital
City
Herston
State/Province
Queensland
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide SA
State/Province
South Australia
Country
Australia
Facility Name
Flinders Medical Center
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
Saint Vincents Hospital
City
Fitzroy
State/Province
Victoria
Country
Australia
Facility Name
Western Hospital
City
Footscray
State/Province
Victoria
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Box Hill Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
Country
Australia
Facility Name
Fremantle Hospital
City
Fremantle
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
Country
Australia
Facility Name
Heritage Med Research Clinic, Univ of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
University of Alberta, Zeidler Ledcore Centre
City
Zeidler Ledcore Centre
State/Province
Alberta
Country
Canada
Facility Name
Gastrointestional Research Institute
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Gordon & Leslie Diamond Health Care Centre
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Liver and Intestinal Research Centre
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
The Ottawa Hospital,Division of Infectious Diseases
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Hôpital Beaujon, Service Hepatologie- Centre Pierre Abrami
City
Clichy
State/Province
Cedex
Country
France
Facility Name
Hôpital de la Croix Rousse
City
Lyon
State/Province
Cedex
Country
France
Facility Name
Hopital Tenon
City
Paris
Country
France
Facility Name
Centre Hospitalier Universitaire de Rennes
City
Rennes Cedex 9
Country
France
Facility Name
Hopital Charles Nicolle
City
Rouen
Country
France
Facility Name
Centre Hospitalier Regional et Universitaire de Strasbourg, Hopital Civil
City
Strasbourg
Country
France
Facility Name
Centre Hospitalier Universitaire Purpan
City
Toulouse
Country
France
Facility Name
Hopital Paul Brousse
City
Villejuif Cedex
Country
France
Facility Name
Johannes Gutenberg-Universitat Mainz,
City
Mainz
State/Province
Rheinland-pfalz
Country
Germany
Facility Name
Charite Berlin
City
Berlin
Country
Germany
Facility Name
Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie,
City
Essen
Country
Germany
Facility Name
Johann-Wolfgang-Goethe Universitat,
City
Frankfurt
Country
Germany
Facility Name
Asklepios Westklinikum
City
Hamburg
Country
Germany
Facility Name
Medizinische Hochschule Hannover,Hastroenterologie und Hepatologie
City
Hannover
Country
Germany
Facility Name
Universitatsklinik Koln
City
Köln
Country
Germany
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
Country
Germany
Facility Name
Ippokratio Hospital Salonica
City
Thessaloniki
State/Province
Attica
Country
Greece
Facility Name
Ippokratio Hospital Athens
City
Attica
Country
Greece
Facility Name
General University Hospital of Patras
City
Patra
Country
Greece
Facility Name
Hippokration General Hospital of Thessaloniki
City
Thessaloniki
Country
Greece
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Princess Margaret Hospital
City
Kowloon
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Facility Name
Alice Ho Miu Ling Nethersole Hospital
City
Tai Po
Country
Hong Kong
Facility Name
Global Hospital, Lakdi Ka Pul
City
Hyderabad
State/Province
Andhra Pradesh
Country
India
Facility Name
Institute of digestive and liver disease, Dispur Hospital Ganeshguri
City
Guwahati
State/Province
Assam
Country
India
Facility Name
Vedanta Institute of Medical Sciences
City
Ahmedabad
State/Province
Gujarat
Country
India
Facility Name
Liver Clinic
City
Surat
State/Province
Gujarat
Country
India
Facility Name
Manipal Hospitals
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Department of Hepatology, Institute of Liver Diseases, HPB Surgery and Transplant, Global Hospital
City
Mumbai
State/Province
Maharashtra
Country
India
Facility Name
Seth GS Medical College and KEM Hospital, Acharya Donde Marg,Parel
City
Mumbai
State/Province
Maharashtra
Country
India
Facility Name
Midas Institute of Gastroenterology
City
Nagpur
State/Province
Maharashtra
Country
India
Facility Name
Dharamasi Hospital,Chandni Chowk, South Shivajinagar,
City
Sangli
State/Province
Maharashtra
Country
India
Facility Name
All India Institute of Medical Sciences, Ansari Nagar
City
Delhi
State/Province
New Delhi
Country
India
Facility Name
VGM Hospital
City
Coimbatore
State/Province
Tamil Nadu
Country
India
Facility Name
Institute of Post Graduate Medical Education And Research
City
Kolkata
State/Province
West Bengal
Country
India
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
Country
India
Facility Name
Azienda Ospedaliero-Universitaria di Cagliari
City
Monserrato
State/Province
Cagliari
Country
Italy
Facility Name
Fondazione IRCCS Ca Granda - Ospedale Maggiore Policlinico
City
Milano
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
Country
Italy
Facility Name
Seconda Universita degli Studi di Napoli
City
Napoli
Country
Italy
Facility Name
Azienda Ospedaliera di Parma,Department of Infectious Diseases and hepatology
City
Parma
Country
Italy
Facility Name
Fondazione PTV - Policlinico Tor Vergata
City
Roma
Country
Italy
Facility Name
Policlinico Umberto I
City
Rome
Country
Italy
Facility Name
University of Milan,Azienda Ospedaliera San Giovanni, Battista di Torino,Dipartimento di Gastroenterologia
City
Torino
Country
Italy
Facility Name
SoonChunHyang University Hospital Cheonan
City
Cheonan
State/Province
Chungcheon
Country
Korea, Republic of
Facility Name
Yonsei Unversity Wonju College of Medicine Wonju Christian Hospital
City
Wonju
State/Province
Gangwon-do
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital
City
Ansan-si
State/Province
Gyeonggi-d
Country
Korea, Republic of
Facility Name
Bucheon St. Mary's Hospital
City
Bucheon
State/Province
Gyeonggi-d
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
State/Province
Gyeonggi-d
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center, CHA University
City
Sungnam
State/Province
Gyeonggi-d
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
State/Province
Gyeongsang
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
State/Province
Gyeongsang
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeongsang
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Inje University Ilsan Paik Hospital
City
Goyang, Gyeonggi-Do
Country
Korea, Republic of
Facility Name
Digestive Disease Cntr, Konkuk Univ Hosp
City
Kwangjin-gu, Seoul
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Saint Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Academisch Medisch Centrum
City
Amsterdam
Country
Netherlands
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
Country
Netherlands
Facility Name
Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi
City
Lodz
State/Province
Lodzkie
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny 1,Klinika Chorób Zakaznych,ulica Staszica 16
City
Lublin
State/Province
Lubelskie
Country
Poland
Facility Name
Szpital Specjalistyczny w Chorzowie
City
Chorzów
State/Province
Slaskie
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny Kazimierza Dluskeigo w Bialymstoku
City
Bialystok
Country
Poland
Facility Name
Wojewódzki Szpital Obserwacyjno Zakazny im. Tadeusza Browicza
City
Bydgoszcz
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie
City
Krakow
Country
Poland
Facility Name
Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi
City
Lodz
Country
Poland
Facility Name
SP ZOZ Wojewodzki Szpital Zakazny
City
Warszawa
Country
Poland
Facility Name
Hospital de Egas Moniz
City
Lisboa
Country
Portugal
Facility Name
Hospital de Santa Maria
City
Lisboa
Country
Portugal
Facility Name
Centro Hospitalar do Porto
City
Porto
Country
Portugal
Facility Name
Hospital São João
City
Porto
Country
Portugal
Facility Name
Neomed Research
City
Brasov
Country
Romania
Facility Name
Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
City
Bucharest
Country
Romania
Facility Name
Institutul National de Boli Infectioase Prof.Dr. Matei Bals
City
Bucharest
Country
Romania
Facility Name
Spitalul Clinic de Boli Infectioase si Tropicale "Dr. Victor Babes"
City
Bucharest
Country
Romania
Facility Name
Spitalul Clinic Colentina
City
Bucuresti
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Sibiu
City
Sibiu
Country
Romania
Facility Name
Cabinet Particular Policlinic Algomed SRL-Gastroenterologie
City
Timisoara
Country
Romania
Facility Name
Changi General Hospital
City
Singapore
Country
Singapore
Facility Name
National University Hospital Singapore
City
Singapore
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
Country
Singapore
Facility Name
Tan Tock Seng Hospital
City
Singapore
Country
Singapore
Facility Name
Hospital General Universitari Vall d' Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Carlos III
City
Madrid
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
Country
Spain
Facility Name
Hospital Virgen de la Victoria
City
Malaga
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
Country
Spain
Facility Name
Hospital Meixoeiro
City
Vigo, Pontevedra
Country
Spain
Facility Name
Far-Eastern Memorial Hosp
City
New Taipei City
State/Province
Banciao Dist
Country
Taiwan
Facility Name
Chang Gung Medical Foundation.LinKou Branch
City
Tao-Yuan
State/Province
Taoyuan
Country
Taiwan
Facility Name
Changhua Christain Hospital
City
Changhua
Country
Taiwan
Facility Name
Chiayi Christian Hosp
City
Chia-Yi
Country
Taiwan
Facility Name
Buddhist Tzu Chi General Hospital
City
Hualien
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Kaohsiung Medical University Hospital
City
Kaosiung
Country
Taiwan
Facility Name
Chang Gung Medical Foundation-Keelung
City
Keelung Town/KEELUNG CITY
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
Taichung Veterans Genl Hosp
City
Taichung
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
Cathay General Hospital
City
Taipei
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Ankara Üniversitesi Tip Fakültesi
City
Ankara
Country
Turkey
Facility Name
Hacettepe Üniversitesi Tip Fakültesi
City
Ankara
Country
Turkey
Facility Name
Gaziantep Üniversitesi Tip Fakültesi, Sahinbey Arastirma ve Uygulama Hastanesi
City
Gaziantep
Country
Turkey
Facility Name
Istanbul Universitesi Istanbul Tip Fakultesi
City
Istanbul
Country
Turkey
Facility Name
Mersin Üniversitesi Tip Fakültesi, Saglik Arastirma ve Uygulama Hastanesi
City
Mersin
Country
Turkey
Facility Name
The Queen Elizabeth Hospital
City
Birmingham, WSTMID
Country
United Kingdom
Facility Name
Royal Free Hospital
City
Hampstead,London
Country
United Kingdom
Facility Name
Barts and The London NHS Trust
City
London
Country
United Kingdom
Facility Name
King's College Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26453773
Citation
Marcellin P, Ahn SH, Ma X, Caruntu FA, Tak WY, Elkashab M, Chuang WL, Lim SG, Tabak F, Mehta R, Petersen J, Foster GR, Lou L, Martins EB, Dinh P, Lin L, Corsa A, Charuworn P, Subramanian GM, Reiser H, Reesink HW, Fung S, Strasser SI, Trinh H, Buti M, Gaeta GB, Hui AJ, Papatheodoridis G, Flisiak R, Chan HL; Study 149 Investigators. Combination of Tenofovir Disoproxil Fumarate and Peginterferon alpha-2a Increases Loss of Hepatitis B Surface Antigen in Patients With Chronic Hepatitis B. Gastroenterology. 2016 Jan;150(1):134-144.e10. doi: 10.1053/j.gastro.2015.09.043. Epub 2015 Oct 8.
Results Reference
result
PubMed Identifier
26143444
Citation
Chan HL, Elkhashab M, Trinh H, Tak WY, Ma X, Chuang WL, Kim YJ, Martins EB, Lin L, Dinh P, Charuworn P, Foster GR, Marcellin P. Association of baseline vitamin D levels with clinical parameters and treatment outcomes in chronic hepatitis B. J Hepatol. 2015 Nov;63(5):1086-92. doi: 10.1016/j.jhep.2015.06.025. Epub 2015 Jul 2.
Results Reference
result

Learn more about this trial

Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B

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